Working… Menu
Trial record 1 of 1 for:    "Barrett Esophagus" | "Zinc"
Previous Study | Return to List | Next Study

Effect of Zinc on Barrett's Metaplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01984580
Recruitment Status : Unknown
Verified November 2013 by James M. Mullin, Ph.D., Main Line Health.
Recruitment status was:  Recruiting
First Posted : November 14, 2013
Last Update Posted : November 14, 2013
Sharpe-Strumia Research Foundation
Information provided by (Responsible Party):
James M. Mullin, Ph.D., Main Line Health

Brief Summary:

Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:

  1. can this zinc administration cause molecular-level changes in the Barrett's tissue?
  2. are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?

Condition or disease Intervention/treatment Phase
Barrett's Metaplasia Drug: zinc gluconate Phase 1

Detailed Description:
14 days prior to already-scheduled upper endoscopy (EGD) procedures for routine surveillance of Barrett's tissue, patients who have given written, informed consent are randomized (sealed envelope method) and placed on an oral dose of zinc gluconate (26.6 mg zinc BID) or a placebo (molar equivalent of sodium gluconate BID) for 14 days. At the time of endoscopy, 4 biopsies are taken (and pooled) from the Barrett's tissue and 4 from proximal normal esophageal tissue. Biopsies are flash frozen for later analyses by atomic absorption spectroscopy, PAGE and Western immunoblot or RNA microarray.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Zinc on Barrett's Metaplasia
Study Start Date : April 2011
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zinc Drug: zinc gluconate
26.6 mg zinc BID (as zinc gluconate)

Placebo Comparator: sodium

Primary Outcome Measures :
  1. Changes in zinc-regulated cellular proteins within Barrett's tissue [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]

Secondary Outcome Measures :
  1. Changes in cellular microRNA profile; changes in protein cancer biomarkers [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:ages 18-80; prior diagnosis of Barrett's esophagus -

Exclusion Criteria:unable to provide written, informed consent; prior history of Barrett's dysplasia or esophageal adenocarcinoma; drug exclusions: hormone replacement therapy, cholestyramine, amiloride diuretics, oral quinolone antibiotics, glucocorticoids, corticosteroids, anticoagulants (other than aspirin)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01984580

Layout table for location contacts
Contact: James M Mullin, Ph.D. 484-476-2708

Layout table for location information
United States, Pennsylvania
Lankenau Institute for Medical Research Recruiting
Wynnewood, Pennsylvania, United States, 19096
Sponsors and Collaborators
Main Line Health
Sharpe-Strumia Research Foundation

Layout table for additonal information
Responsible Party: James M. Mullin, Ph.D., Professor, Main Line Health Identifier: NCT01984580     History of Changes
Other Study ID Numbers: F/N-R-11-3038L
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Keywords provided by James M. Mullin, Ph.D., Main Line Health:
Barrett's esophagus
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Pathologic Processes
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs